Management made a comment about whether the FDA still viewed the Ph3 trials as confirmatory given the change in endpoints.
Operator
And our next question comes from the line of Thomas Wei with Jefferies. Please go ahead.
Thomas A. Wei
Analyst, Jefferies LLC
Thanks. Just on the ECHELON-1 and -2 changes, should I be thinking of it becoming something likea landmark PFS analysis? Is that what you're thinking of, like switching the endpoint to a responder analysis, that the proportion that get to one year – what the one year PFS rate is or the three-year PFSrate is, kind of similar to what you did with the AETHERA trial?
And then my second question on AETHERA was just a reminder again of, there were a lot ofconcerns that had been raised at the FDA panel on the design of AETHERA, which led them to saythat it could not be the confirmatory study for approval. Can you just remind us what those concernswere and how we should think about that as the AETHERA data approaches here? Thanks.
Clay B. Siegall
Chairman, President & Chief Executive Officer, Seattle Genetics, Inc.
Yes. First of all, you asked a question about the ECHELON-1, ECHELON-2 trials and what kind of potential changes. And I use that word potential, because this is with discussions with our partner,with regulatory people. So nothing can be written into anything that we are either contemplating now.But your comment, could it be a landmark analysis instead of a event-driven analysis, like such aswhat we did with AETHERA. That is one of the options. When we look at all the different options, thatcertainly is not one we're throwing off the table. But I don't want to guide you that that will be it yet.We're still in discussions and contemplating all of the information before any specifics will be made.But I do appreciate your comment and that that is certainly one of the multiple of things that couldhappen.
As far as AETHERA, you do remember correctly. There were some issues that the FDA brought up to not make it a confirmatory trial, that it would be something that they wanted in – they wanted for thesafety database for certain. So that's written in there, but as far as confirmatory, it was not. And I thinkthere was a lot of different discussions up and down on AETHERA. It's our assessment that whenwe complete this trial, if the data are good and that's what we certainly are hoping for. And if the dataare good, our intention is to submit this and we believe that if the data are strong that we submitted,that it would be a review decision by the agency.
